K254247
- 510(k) number
- K254247
- Device name
- OSTEOMNI SPINAL FIXATION SYSTEM
- Applicant
- Osteomni, Inc. FL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-02-24
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K254247.pdf
Official FDA record: K254247
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.